- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669084
Innate and Acquired Resistance to Plasmodium Falciparum Malaria in Mali
Studies of Innate and Acquired Resistance to P. Falciparum Malaria in Mali
This study, sponsored by NIAID and the University of Bamako, Mali, will identify genetic and other factors that may protect against severe malaria in some children.
Children between 6 months and 17 years of age who live in Kenieroba, Fourda or Bozokin villages in Mali may enroll in the study. Participants have a blood sample collected by finger prick with a small needle. The blood is examined for gene variants that influence the severity of disease in children exposed to the malaria parasite.
Children who develop a fever or other symptoms of malaria are evaluated and treated in Kenieroba s health center for up to 5 years from entering the study, or until they reach 18 years of age. The children are treated with artesunate and amodiaquine. Children with severe disease are treated with quinine. One tablespoon of blood is drawn from the children for study.
At the end of the dry season and the wet season, a subset of 200 healthy children are asked to provide 1 or 2 tablespoons of blood, drawn through a needle placed in a vein in the arm. Additional research blood samples may be requested from children between 2 and 17 years old. Blood will not be taken from any child more than twice a year.
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Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bamako, Mali
- University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
(Cohort Study)
- Resident of Kenieroba, Fourda, or Bozokin villages, and no plans to relocate away from the study village for the next 5 years.
- Willingness to participate in the study as evidenced by informed consent of parents or guardians of children, and willingness to bring children to study clinic if they develop fever or other symptoms of malaria.
- Age 6 months to 17 years.
(Blood Collection Study)
- Children enrolled in the cohort study.
- Willingness to participate in the study as evidenced by informed consent of parents or guardians of children.
- Age 2 years to 14 years.
- Hemoglobin level greater than or equal to 8.5g/dL.
(Parasite Clearance Study)
- Children enrolled in the cohort study.
- Willingness to participate in the study as evidenced by informed consent of parents or guardians of children.
- Age 1 year to 17 years (inclusive).
- P. falciparum density greater than or equal to 10,000/microL.
- Present with their first episode of uncomplicated malaria of the 2010 transmission season or any episode during the 2012 transmission season.
- Resident of Kenieroba
(Adult blood Collection Study)
- Willingness to participate in the study as evidenced by informed consent.
- Age 18 years to 65 years.
- Hemoglobin level greater than or equal to 8.5 g/dL
EXCLUSION CRITERIA:
(Cohort Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS) or to the child (e.g., severe malnutrition).
(Blood Collection Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS) or to the child (e.g., severe malnutrition).
(Parasite Clearance Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric diesase).
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS) or to the child (e.g., severe malnutrition).
- Pregnancy at the time of malaria episode.
(Adult Blood Collection Study)
- Any condition that in the opinion of the investigator would render the subject unable to comply with the protocol (e.g., psychiatric disease)
- Any health condition that in the opinion of the investigator would confound data analysis or pose unnecessary exposure risks to study personnel (e.g., individuals who are known to be HIV-infected or to have AIDS.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- Fairhurst RM, Baruch DI, Brittain NJ, Ostera GR, Wallach JS, Hoang HL, Hayton K, Guindo A, Makobongo MO, Schwartz OM, Tounkara A, Doumbo OK, Diallo DA, Fujioka H, Ho M, Wellems TE. Abnormal display of PfEMP-1 on erythrocytes carrying haemoglobin C may protect against malaria. Nature. 2005 Jun 23;435(7045):1117-21. doi: 10.1038/nature03631.
- Guindo A, Fairhurst RM, Doumbo OK, Wellems TE, Diallo DA. X-linked G6PD deficiency protects hemizygous males but not heterozygous females against severe malaria. PLoS Med. 2007 Mar;4(3):e66. doi: 10.1371/journal.pmed.0040066.
- Luzzatto L, Usanga FA, Reddy S. Glucose-6-phosphate dehydrogenase deficient red cells: resistance to infection by malarial parasites. Science. 1969 May 16;164(3881):839-42. doi: 10.1126/science.164.3881.839.
- Lopera-Mesa TM, Doumbia S, Konate D, Anderson JM, Doumbouya M, Keita AS, Diakite SA, Traore K, Krause MA, Diouf A, Moretz SE, Tullo GS, Miura K, Gu W, Fay MP, Taylor SM, Long CA, Diakite M, Fairhurst RM. Effect of red blood cell variants on childhood malaria in Mali: a prospective cohort study. Lancet Haematol. 2015 Apr;2(4):e140-9. doi: 10.1016/S2352-3026(15)00043-5. Epub 2015 Mar 24.
- Lopera-Mesa TM, Doumbia S, Chiang S, Zeituni AE, Konate DS, Doumbouya M, Keita AS, Stepniewska K, Traore K, Diakite SA, Ndiaye D, Sa JM, Anderson JM, Fay MP, Long CA, Diakite M, Fairhurst RM. Plasmodium falciparum clearance rates in response to artesunate in Malian children with malaria: effect of acquired immunity. J Infect Dis. 2013 Jun 1;207(11):1655-63. doi: 10.1093/infdis/jit082. Epub 2013 Feb 28.
- Mita-Mendoza NK, van de Hoef DL, Lopera-Mesa TM, Doumbia S, Konate D, Doumbouya M, Gu W, Anderson JM, Santos-Argumedo L, Rodriguez A, Fay MP, Diakite M, Long CA, Fairhurst RM. A potential role for plasma uric acid in the endothelial pathology of Plasmodium falciparum malaria. PLoS One. 2013;8(1):e54481. doi: 10.1371/journal.pone.0054481. Epub 2013 Jan 22.
- Lopera-Mesa TM, Mita-Mendoza NK, van de Hoef DL, Doumbia S, Konate D, Doumbouya M, Gu W, Traore K, Diakite SA, Remaley AT, Anderson JM, Rodriguez A, Fay MP, Long CA, Diakite M, Fairhurst RM. Plasma uric acid levels correlate with inflammation and disease severity in Malian children with Plasmodium falciparum malaria. PLoS One. 2012;7(10):e46424. doi: 10.1371/journal.pone.0046424. Epub 2012 Oct 5.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999908120
- 08-I-N120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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